Phenobarbital for Acute Alcohol Withdrawal
Information source: Alameda County Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Withdrawal
Intervention: 10 mg/kg IV phenobarbital in 100 ml saline (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Jonathan Rosenson
Summary
Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based
alcohol withdrawal protocol will be associated with decreased need for ICU admission,
continuous lorazepam infusion and will not be associated with increased adverse events.
Clinical Details
Official title: Phenobarbital Versus Placebo for Acute Alcohol Withdrawal
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Patients Requiring Continuous Lorazepam InfusionPercentage of Patients Requiring ICU Admission Total Lorazepam Required Per Patient Per Admission
Secondary outcome: Length of StayNumber of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability Number of Study Patients With Seizure as a Measure of Safety and Tolerability Number of Study Patients With Mortality as a Measure of Safety and Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Need for admission to hospital for acute alcohol withdrawal
Exclusion Criteria:
- allergy to phenobarbital, lorazepam, age<18 or >65
Locations and Contacts
Alameda County Medical Center, Oakland, California 94608, United States
Additional Information
Starting date: January 2009
Last updated: March 7, 2012
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